COPYRIGHTpsasir.upm.edu.my/id/eprint/70695/1/FPSK(P) 2017 20 IR.pdf · sebulan selepas program dan...

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UNIVERSITI PUTRA MALAYSIA

EFFECTIVENESS OF GROUP COGNITIVE BEHAVIORAL-BASED THERAPY ON PAIN, FUNCTIONAL DISABILITY AND PSYCHOLOGICAL

OUTCOMES AMONG KNEE OSTEOARTHRITIS PATIENTS IN MALAYSIAN GOVERNMENT HOSPITALS

FOO CHAI NIEN

FPSK(P) 2017 20

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PMEFFECTIVENESS OF GROUP COGNITIVE BEHAVIORAL-BASED

THERAPY ON PAIN, FUNCTIONAL DISABILITY AND PSYCHOLOGICAL OUTCOMES AMONG KNEE OSTEOARTHRITIS PATIENTS IN

MALAYSIAN GOVERNMENT HOSPITALS

By

FOO CHAI NIEN

Thesis Submitted to the School of Graduate Studies, Universiti Putra Malaysia in Fulfilment of the Requirements for the Degree of Doctor

Philosophy

March 2017

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All material contained within the thesis, including without limitation text, logos, icons, photographs and all other artwork, is copyright material of Universiti Putra Malaysia unless otherwise stated. Use may be made of any material contained within the thesis for non-commercial purposes from the copyright holder. Commercial use of material may only be made with the express, prior, written permission of Universiti Putra Malaysia. Copyright © Universiti Putra Malaysia

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Abstract of thesis presented to the Senate of Universiti Putra Malaysia in fulfilment of the requirement for the degree of Doctor of Philosophy

EFFECTIVENESS OF GROUP COGNITIVE BEHAVIORAL-BASED THERAPY ON PAIN, FUNCTIONAL DISABILITY AND PSYCHOLOGICAL

OUTCOMES AMONG KNEE OSTEOARTHRITIS PATIENTS IN MALAYSIAN GOVERNMENT HOSPITALS

By

FOO CHAI NIEN

March 2017

Chairman : Professor Manohar a/l Arumugam, MS Faculty : Medicine and Health Sciences

Background: Knee osteoarthritis (OA) mainly causes pain, stiffness and muscle weakness. It also affects individual’s physical functioning. It has great impact on individual’s quality of life and wellbeing. Anti-inflammatory drugs and knee replacement are the mainstay methods in the management of knee OA in Malaysia. It is still noted that individuals with knee OA suffer from low quality of life. Non-pharmacological interventions are still a driving force in managing knee OA pain. Cognitive behavioral-based therapy is a first line psychosocial treatment which is more applied in chronic pain conditions. Evidence of effectiveness of cognitive behavioral-based therapy in treating OA knee pain is lacking.

Objective: This study aimed to develop, implement, and evaluate the effectiveness of a cognitive behavioral-based therapy module in treating knee pain, functional disability and psychological outcomes for patients with knee OA.

Methodology: A two arm parallel-group unblinded randomized controlled study design was used in this study. Three hundred patients aged 35 to 75 years diagnosed with knee OA (Kellgren grade ≥2 and visual analogue scale (VAS) score 40 or more) were recruited from Orthopaedics clinic of Hospital Putrajaya and Hospital Serdang, Malaysia. A cognitive behavioral-based therapy module was developed based on the cognitive-behavioral model. Eligible patients were randomized by applying independently operated computer- generated random sequence system with the block randomization of six (http://random-allocation-software.software.informer.com/2.0/). Participants in intervention group (n=150) received a three sessions of a group

http://random-allocation-software.software.informer.com/2.0/

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cognitive behavioral intervention (two and a half hour for each session) in addition to standard routine care and participants in control group (n=150) received standard routine care. A set of self-administered validated and reliable structured questionnaire was used for data collection. Data was collected at baseline, immediate, one month and six months post treatment. Primary outcome measure was knee pain intensity. Secondary outcome measures included functional disability (daily living and sport), depression, anxiety, stress, fear-avoidance beliefs (physical activity and work), pain catastrophising and pain self-efficacy. Data collected was analyzed using SPSS software with the application of mixed design repeated measured analysis of variance. Results: One hundred and nineteen (79%) participants in the intervention

group and 111 (74%) participants in the control group were included in the analysis at six months. The Knee injury and Osteoarthritis Outcome Score (KOOS) knee pain scores improved substantially in the intervention group, but not in the control group. The mean change in the KOOS knee pain score was 8.9 points (95% CI -11.23 to -6.62, p=0.0001) higher (less knee pain intensity) in the intervention group. Functional disability in daily living, depression, anxiety, pain catastrophising, and pain self-efficacy level improved significantly in the intervention group (p0.05). Conclusion: The cognitive behavioral-based therapy module is effective in reducing knee pain intensity, functional disability in daily living, depression, anxiety, pain catastrophising, and improving pain self-efficacy level in this knee OA population. Keywords: cognitive behavioral, knee pain, functional disability, psychological outcomes, randomized controlled trial

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Abstrak tesis yang dikemukakan kepada Senat Universiti Putra Malaysia sebagai memenuhi keperluan untuk ijazah Doktor Falsafah

KEBERKESANAN KOGNITIF TINGKAHLAKU TERAPI SECARA BERKUMPULAN PADA SAKIT, KEMUDARATAN DAN KECACATAN

DAN PSIKOLOGI ANTARA PESAKIT-PESAKIT OSTEOARTRITIS LUTUT YANG DIJUMPAI DI HOSPITAL KERAJAAN MALAYSIA

Oleh

FOO CHAI NIEN

Mac 2017

Pengerusi : Profesor Manohar a/l Arumugam, MS Fakulti : Perubatan dan Sains Kesihatan

Latar belakang: Osteoartritis (OA) lutut akan menyebabkan kesakitan,

kekejangan dan melemahkan otot. Ia turut menjejaskan fungsi fizikal dan menyebabkan kesan negatif kepada kualiti hidup dan kesejahteraan seseorang individu. Penggunaan ubat anti-keradangan dan pembedahan ganti lutut merupakan salah satu kaedah konvensional dalam menangani masalah OA lutut di Malaysia. Akan tetapi seseorang individu yang dijangkiti OA lutut masih akan mengalami kualiti hidup yang rendah. Oleh itu, penglibatan intervensi selain daripada farmakologi adalah amat diperlukan dalam pengurusan kesakitan OA lutut. Kognitif terapi tingkahlaku adalah salah satu amalan terbaik dan berkesan dalam menangani pelbagai keadaan sakit kronik. Walau bagaimanapun, masih kekurangan bukti penggunaannya dan amalan dalam merawat OA lutut.

Objektif: Kajian ini bertujuan untuk membangunkan, melaksanakan, dan

menilai keberkesanan modul kognitif terapi tingkahlaku dalam mengurangkan kesakitan lutut, meningkatkan fungsi kecacatan dan aspek psikologi untuk pesakit OA lutut.

Metodologi: Kajian ini menggunakan percubaan klinikal rabun satu pihak

rawak dua kumpulan. Seramai 300 pesakit yang berumur 35 hingga 75 tahun dengan didiagnosis OA lutut (Kellgren gred ≥2 dan skala analog visual (VAS) yang melebihi 40) dari klinik ortopedik Hospital Putrajaya dan Hospital Serdang, Malaysia. Satu modul kognitif terapi tingkahlaku telah dibangunkan berdasarkan model kognitif tingkahlaku. Peserta di kumpulan intervensi (n=150) menerima tiga sesi kognitif terapi tingkahlaku serta peserta di

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kumpulan kawalan (n=150) hanya menerima penjagaan rutin standard sahaja. Satu set soal selidik yang berstruktur serta telah diuji dengan kebolehpercayaan dan keesahan akan diedarkan untuk pengumpulan data. Soal selidik akan diedar pada semasa permulaan, selepas program, selepas sebulan selepas program dan selepas enam bulan selepas program. Hasil kajian primer yang difokuskan adalah intensiti kesakitan lutut manakala hasil sekunder adalah kecacatan fungsi dalam aktiviti harian hidup, kemurungan, kebimbangan, catastrophising sakit, dan sakit tahap keberkesanan diri. Data dikumpulkan dan dianalisis dengan aplikasi SPSS. Hasil kajian: Seratus dan sembilan belas (79%) orang peserta dalam

kumpulan intervensi dan 111 (74%) orang peserta dalam kumpulan kawalan yang memenuhi syarat telah digolongkan dalam analisis pada bulan ke-enam. Purata skor KOOS sakit lutut telah meningkat sebanyak 8.9 (sakit lutut dikurangkan) (95% CI -11,23 hingga -6,62, p=0.0001) dalam kumpulan intervensi, tetapi tiada peningkatan signifikasi dalam kumpulan kawalan. Kecacatan fungsi dalam aktiviti harian hidup, kemurungan, kebimbangan, catastrophising sakit, dan sakit tahap keberkesanan diri telah meningkat secara ketara dalam kumpulan intervensi, tetapi tidak dalam kumpulan kawalan. Manakala kecacatan fungsi dalam sukan, tekanan dan kepercayaan takut elak tidak terdapat perbezaan yang signifikasi antara kedua-dua kumpulan berkenaan (p>0.05). Kesimpulan: Kognitif tingkahlaku intervensi adalah efektif dalam

mengurangkan intensiti kesakitan lutut, kecacatan fungsi dalam aktiviti harian hidup, kemurungan, kebimbangan, catastrophising sakit, dan sakit tahap keberkesanan diri di kalangan pesakit OA lutut. Kata kunci: kognitif tingkahlaku terapi, sakit lutut, kecacatan fungsi, aspek psikologi, percubaan klinikal rabun

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ACKNOWLEDGEMENTS

Firstly, I would like to express my sincere gratitude to my advisor Prof. Dr. Manohar Arumugam for the continuous support of my PhD study and related research, for his patience, motivation, and immense knowledge. His guidance helped me in all the time of research and writing of this thesis. Besides my advisor, I would like to thank my supervisory committee team members, Prof. Dato’ Dr. Lekhraj Rampal, Prof. Dato’ Dr. Munn-Sann Lye, Prof. Dr. Sherina, and Dr. Zubaidah for their insightful comments and encouragement, but also for the hard question which incented me to widen my research from various perspectives.

My sincere thanks also go to Dr. Fahrudin Che Hamzah, Dr. Vijayachandran, and Dr. Anand Kumar, for their contribution in patient recruitment and screening. A warm thank you to Orthopaedic and Physiotherapy team in Hospital Putrajaya and Hospital Serdang, Madam Haironi, Mr. Wan, Mr. Aimanhafiz, Ms. Izyan, Ms. Amirah, Ms. Siti Hhairiah, Ms. Azliza, Ms. Sri Saliza, Ms. Tuan Nur Hafizah, and Ms. Siti Nur Jamilah who provided their contribution to the intervention manual and intervention program in practice. A special word of appreciation goes to Mr. Anafi and Madam Vasanthi to help during the recruitment process. My sincerest thanks go to all the patients who participated in this study and thus enabled it. Without they precious support it would not be possible to conduct this research.

I thank my fellow schoolmates in for the stimulating discussions and for all the fun we have had in the last three years. I am deeply grateful to my parents, parents in law, and to my brother and sisters for supporting me spiritually throughout writing this thesis. And finally thanks to my husband, and our daughter and son, for their love, patience, encouragement, and belief in me.

This study has been financially supported by Research Medical Centre grants (04-02-12-1746RU) from Universiti of Putra Malaysia.

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This thesis was submitted to the Senate of Universiti Putra Malaysia and has been accepted as fulfilment of the requirement for the degree of Doctor of Philosophy. The members of the Supervisory Committee were as follows:

Manohar Arumugam, MBBS, MS (Orthopaedic Surgery)

Professor Faculty of Medicine and Health Sciences Universiti Putra Malaysia (Chairman)

Lekhraj Rampal, MBBS, MPH, DrPH, FRSH, FAMM, FAMS Professor Faculty of Medicine and Health Sciences Universiti Putra Malaysia (Member)

Munn-Sann Lye, MBBS, MPH, DrPH

Professor Faculty of Medicine and Health Sciences Universiti Putra Malaysia (Member)

Sherina Mohd Sidik, MBBS, MMED, PhD Professor Faculty of Medicine and Health Sciences Universiti Putra Malaysia (Member)

Zubaidah Jamil @ Osman, BSc, MA, DClinPsych

Senior Lecturer Faculty of Medicine and Health Sciences Universiti Putra Malaysia (Member)

_________________________

ROBIAH BINTI YUNUS, PhDProfessor and Dean School of Graduate Studies Universiti Putra Malaysia

Date:

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Declaration by graduate student

I hereby confirm that:

this thesis is my original work;

quotations, illustrations and citations have been duly referenced;

this thesis has not been submitted previously or concurrently for any otherdegree at any other institutions;

intellectual property from the thesis and copyright of thesis are fully-ownedby Universiti Putra Malaysia, as according to the Universiti Putra Malaysia(Research) Rules 2012;

written permission must be obtained from supervisor and the office ofDeputy Vice-Chancellor (Research and Innovation) before thesis ispublished (in the form of written, printed or in electronic form) includingbooks, journals, modules, proceedings, popular writings, seminar papers,manuscripts, posters, reports, lecture notes, learning modules or any othermaterials as stated in the Universiti Putra Malaysia (Research) Rules2012;

there is no plagiarism or data falsification/fabrication in the thesis, andscholarly integrity is upheld as according to the Universiti Putra Malaysia(Graduate Studies) Rules 2003 (Revision 2012-2013) and the UniversitiPutra Malaysia (Research) Rules 2012. The thesis has undergoneplagiarism detection software.

Signature: _______________________ Date: __________________

Name and Matric No.: Foo Chai Nien, GS35465

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Declaration by Members of Supervisory Committee

This is to confirm that:

the research conducted and the writing of this thesis was under oursupervision;

supervision responsibilities as stated in the Universiti Putra Malaysia(Graduate Studies) Rules 2003 (Revision 2012-2013) are adhered to.

Signature:

Name of Chairman of Supervisory Committee:

Signature:

Name of Member of Supervisory Committee:

Signature:


Signature:


Signature:


Signature:


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TABLE OF CONTENTS

Page ABSTRACT i ABSTRAK iii ACKNOWLEDGEMENTS v APPROVAL vi DECLARATION viii LIST OF TABLES xvi LIST OF FIGURES xxii LIST OF ABBREVIATIONS xxiii

1 INTRODUCTION 1

1.1 Background 1 1.2 Statement of the problem 3 1.3 Significance of the study 5 1.4 Research questions 5 1.5 General objective 6 1.6 Specific objectives 6 1.7 Research hypothesis 7

2 LITERATURE REVIEW 8

2.1 Literature search strategy 8 2.2 Epidemiology of OA 8

2.2.1 Definitions and grading of OA 9 2.2.2 Prevalence of Knee OA 9 2.2.3 Incidence and progression of knee OA 11 2.2.4 Clinical features and diagnosis of knee OA 12

2.2.4.1 Symptomatic knee OA 12 2.2.4.2 Radiographic knee OA 13

2.2.5 Markers of tissue damage 16 2.2.6 Risk factors for OA 17

2.2.6.1 Systemic factors 18 2.2.6.2 Local biomechanical risk factors 21

2.3 The burden of OA 23 2.3.1 Disability 23 2.3.2 Mortality 24 2.3.3 Economic burden 24 2.3.4 The impact of OA on quality of life 25

2.4 Prevention 26 2.4.1 Primary prevention 26 2.4.2 Secondary prevention 27

2.4.2.1 Early detection of knee OA 27 2.4.2.2 Early treatment of knee OA 27

2.4.3 Tertiary prevention 28 2.4.3.1 Pharmacological management 29 2.4.3.2 Non-pharmacological management 33

2.5 Cognitive behavioural framework in pain psychology 38

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2.5.1 Pain theories 38 2.5.2 Cognitive behavioural model 39 2.5.3 Psychological perspectives on pain and functional

disability 39 2.5.3.1 Emotional variables 40 2.5.3.2 Cognitive variables 41 2.5.3.3 Behavioural variables 41

2.5.4 Conceptual framework 42

3 METHODOLOGY 44

3.1 Study location 44 3.2 Study design 44

3.2.1 Randomization and blinding procedure 45 3.3 Study duration 46 3.4 Study population 46 3.5 Sample size estimation 46 3.6 Inclusion criteria 47 3.7 Exclusion criteria 47 3.8 Sampling technique 47

3.8.1 Sampling frame 47 3.8.2 Sampling unit 47

3.9 The Knee Book on knee OA 48 3.10 Development of the cognitive behavioural-based therapy

module on Knee OA 48 3.10.1 Quality control of the module 53

3.10.1.1 Content validation 53 3.10.1.2 Pre test 53

3.11 Intervention 54 3.11.1 The implementation of cognitive behavioral-based

therapy module on knee OA 54 3.11.2 Quality control of the intervention 56

3.11.2.1 Training of therapists 56 3.12 Data collection 57

3.12.1 Instrument 60 3.12.2 Anthropometric measurement 61

3.13 Quality control of the instrument 62 3.13.1 Content validity 62 3.13.2 Face validity 62 3.13.3 Pilot test of questionnaire 63

3.13.3.1 Reliability and validity of pilot test

questionnaire 63 3.14 Independent and dependent variables 75 3.15 Conceptual definition of terms 75 3.16 Operational definition of terms 77 3.17 Ethical consideration 78 3.18 Data analysis 78

3.18.1 Test of normality 78 3.18.2 Descriptive statistics 79 3.18.3 Inferential statistics 79

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4 RESULTS 80 4.1 Response rate 80 4.2 Compliance of cognitive behavioural-based therapy

intervention 82 4.3 Fidelity of cognitive behavioural-based therapy intervention 82

4.3.1 Therapists’ competence 82 4.3.2 Therapy quality 82

4.3.2.1 Internal reliability 82 4.3.2.2 Inter rater reliability for total scores 83

4.3.3 Clients satisfaction 83 4.4 Descriptive analysis 84

4.4.1 Baseline socio-demographic and clinical characteristics of participants 84

4.4.2 Baseline knee pain, functional disability, psychological distress, fear-avoidance beliefs, pain catastrophising and pain self-efficacy level of the participants 87

4.5 Test assumptions of parametric test 89 4.5.1 Outliers 89 4.5.2 Data normality 89 4.5.3 Equality of variance 90 4.5.4 Multicollinearity 90 4.5.5 Data reliability and validity 92

4.5.5.1 Internal consistency reliability and indicator reliability 94

4.5.5.2 Convergent validity 97 4.5.5.3 Discriminant validity 98

4.6 Comparison between groups (baseline sample N=300, per protocol sample N=218 and intention to treat sample N=230) 103 4.6.1 Baseline comparison on socio-demographic and

clinical characteristics (N=300) 103 4.6.2 Baseline comparison on outcome measures (N=300) 106 4.6.3 Per protocol sample comparison on socio-

demographic and clinical characteristics between groups (N=218) 107

4.6.4 Intention to treat sample comparison on socio-demographic and clinical characteristics between groups (N=230) 109

4.7 Evaluation of the effectiveness of the intervention on primary outcome and secondary outcome measures (intention to treat sample, N=230) 112 4.7.1 KOOS knee pain 112

4.7.1.1 Assumptions in mixed designs 112 4.7.1.2 Group comparison on KOOS knee pain

score at different time points 113 4.7.1.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean KOOS knee pain score 113

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4.7.1.4 Multiple pairwise time comparisons for intervention and control group 115

4.7.2 KOOS functional disability (daily living) 117 4.7.2.1 Assumptions in mixed designs 117 4.7.2.2 Group comparison on KOOS functional

disability (daily living) at different time points 117

4.7.2.3 The main effect of group, time, age, gender, BMI status, and group x time interaction on mean KOOS functional disability (daily living) score 118


4.7.3 KOOS functional disability (sport) 123 4.7.3.1 Assumptions in mixed designs 123 4.7.3.2 Group comparison on KOOS functional

disability (sport) at different time points 123 4.7.3.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean KOOS functional disability (sport) score 124


4.7.4 Depression 127 4.7.4.1 Assumptions in mixed designs 127 4.7.4.2 Group comparison on depression at

different time points 128 4.7.4.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean depression score 128


4.7.5 Anxiety 132 4.7.5.1 Assumptions in mixed designs 132 4.7.5.2 Group comparison on anxiety at different

time points 132 4.7.5.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean anxiety score 133


4.7.6 Stress 137 4.7.6.1 Assumptions in mixed designs 137 4.7.6.2 Group comparison on stress at different

time points 137 4.7.6.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean stress score 137


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4.7.7 Fear-avoidance beliefs (work) 141 4.7.7.1 Assumptions in mixed designs 141 4.7.7.2 Group comparison on fear-avoidance

beliefs (work) at different time points 142 4.7.7.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean fear-avoidance beliefs (work) score 142


4.7.8 Fear-avoidance beliefs (physical activity) 146 4.7.8.1 Assumptions in mixed designs 146 4.7.8.2 Group comparison on fear-avoidance

beliefs (physical activity) at different time points 146

4.7.8.3 The main effect of group, time, age, gender, BMI status, and group x time interaction on mean fear-avoidance beliefs (physical activity) score 147


4.7.9 Pain catastrophising 151 4.7.9.1 Assumptions in mixed designs 151 4.7.9.2 Group comparison on pain catastrophising

at different time points 151 4.7.9.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean pain catastrophising score 152


4.7.10 Pain self-efficacy 156 4.7.10.1 Assumptions in mixed designs 156 4.7.10.2 Group comparison on pain self-efficacy at

different time points 156 4.7.10.3 The main effect of group, time, age, gender,

BMI status, and group x time interaction on mean pain self-efficacy score 157


4.8 Summary of outcome measures 160 5 DISCUSSION 164

5.1 Response rate 164 5.2 Socio-demographic and clinical characteristics of knee

OA patients 164 5.3 Knee pain intensity level among knee OA patients 165 5.4 Functional disability (daily living and sport) level among

knee OA patients 166 5.5 Psychological distress (depression, anxiety, and stress)

level among knee OA patients 166

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5.6 Fear-avoidance beliefs (physical activity and work) level among knee OA patients 167

5.7 Pain catastrophising level among knee OA patients 168 5.8 Pain self-efficacy level among knee OA patients 169 5.9 Evaluation of the effectiveness of the cognitive behavioral-

based therapy intervention on outcome measures 170 5.9.1 The effect of intervention on knee pain intensity 170 5.9.2 The effect of intervention on functional disability

(daily living and sport) 171 5.9.3 The effect of intervention on psychological distress

(depression, anxiety, and stress) 172 5.9.4 The effect of intervention on fear-avoidance beliefs

(physical activity and work) 1735.9.5 The effect of intervention on pain catastrophising 173 5.9.6 The effect of intervention on pain self-efficacy 173

6 SUMMARY, IMPLICATIONS, RECOMMENDATIONS AND CONCLUSION 174

6.1 Summary 174 6.2 Strengths 176 6.3 Limitations 177 6.4 Implications and recommendations 177 6.5 Conclusion 177

REFERENCES 178 APPENDICES 200 BIODATA OF STUDENT 311PUBLICATION 314

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LIST OF TABLES Table Page

1 Classification criteria for knee OA 14

2 Overview of published work on biomarkers over the past 5 years for knee and hip osteoarthritis 16

3 Cognitive behavioural-based therapy module based on cognitive behavioural model 51

4 Schedule of the assessments 58

5 Summary results on research measurement model 64

6 Average variance extracted and construct reliability of study instruments 65

7 Factor loading, average variance extracted and construct reliability of KOOS pain 66

8 Factor loading, average variance extracted and construct reliability of KOOS functional disability (daily living) 66

9 Factor loading, average variance extracted and construct reliability of KOOS functional disability (sports) 67

10 Factor loading, average variance extracted and construct reliability of depression 67

11 Factor loading, average variance extracted and construct reliability of anxiety 67

12 Factor loading, average variance extracted and construct reliability of stress 67

13 Factor loading, average variance extracted and construct reliability of fear-avoidance beliefs (physical activity) 68

14 Factor loading, average variance extracted and construct reliability of fear-avoidance beliefs (work) 68

15 Factor loading, average variance extracted and construct reliability of PRSS (pain catastrophising) 68

16 Factor loading, average variance extracted and construct reliability of pain self-efficacy 68

17 Fornell-Larker criterion: average variance extracted (on the diagonal) and square correlation coefficient (on the off diagonal) for the study Instruments 70

18 Cross loadings output 71

19 Therapists’ total scores on CTS-R 82

20 Cronbach’s alpha coefficient for two raters 83

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21 Intraclass correlations for raters for total scores on CTS-R; Pearson’s product moment correlations in italics 83

22 T-test comparisons of participants’ satisfaction between groups 84

23 Baseline socio-demographic and clinical characteristics of

randomized participants 85 24 Baseline outcome measures of randomized participants 88

25 Skewness and Kurtosis values of outcome measures 89

26 Levene test of homogeneity of variance for each outcome measures 90

27 VIF and tolerance value of outcome measures 91

28 Summary results on research measurement model 93

29 Factor loading, average variance extracted and construct reliability of KOOS pain 94

30 Factor loading, average variance extracted and construct reliability of KOOS functional disability (daily living) 95

31 Factor loading, average variance extracted and construct reliability of KOOS functional disability (sport) 95

32 Factor loading, average variance extracted and construct reliability of depression 95

33 Factor loading, average variance extracted and construct reliability of anxiety 96

34 Factor loading, average variance extracted and construct reliability of stress 96

35 Factor loading, average variance extracted and construct reliability of fear-avoidance beliefs (physical activity) 96

36 Factor loading, average variance extracted and construct reliability of fear-avoidance beliefs (work) 96

37 Factor loading, average variance extracted and construct reliability of PRSS (pain catastrophising) 97

38 Factor loading, average variance extracted and construct reliability of pain self-efficacy 97

39 AVE for each construct 97

40 Fornell-Larcker criterion: average variance extracted (on the diagonal) and square correlation coefficient (on the off diagonal) for the study Instruments 99

41 Cross loadings output 100

42 Baseline comparison on socio-demographic and clinical characteristics between groups 103

43 Baseline comparison on outcome measures between groups 106

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44 Comparison on socio-demographic and clinical characteristics between groups (per protocol sample) 107

45 Comparison on socio-demographic and clinical characteristics between groups (intention to treat sample without imputation of missing data) 110

46 One-way ANOVA on mean KOOS knee pain score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 113

47 Summary table of mixed repeated measure ANOVA for mean KOOS knee pain score score (between subject effects) 114

48 Summary table of mixed repeated measure ANOVA for mean KOOS knee pain score score (within subject effects) 114

49 Multiple pairwise comparisons of mean KOOS knee pain score for intervention group at baseline, post treatment, one month, and six months follow-up 117

50 Multiple pairwise comparisons of mean KOOS knee pain score for control group at baseline, post treatment, one month, and six months follow-up 117

51 One-way ANOVA on mean KOOS functional disability (daily living) score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 118

52 Summary table of mixed repeated measure ANOVA for mean KOOS functional disability (daily living) score (between subject effects) 119

53 Summary table of mixed repeated measure ANOVA for mean KOOS functional disability (daily living) score (within subject effects) 119

54 Multiple pairwise comparisons of mean KOOS functional disability (daily living) scores for intervention group at baseline, post treatment, one month, and six months follow-up 122

55 Multiple pairwise comparisons of mean KOOS functional disability (daily living) scores for control group at baseline, post treatment, one month, and six months follow-up 122

56 One-way ANOVA on mean KOOS functional disability (sport) score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 123

57 Summary table of mixed repeated measure ANOVA for mean KOOS functional disability (sport) score (between subject effects) 124

58 Summary table of mixed repeated measure ANOVA for mean KOOS functional disability (sport) score (within subject effects) 124

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59 Multiple pairwise comparisons of mean KOOS functional disability (sport) scores for intervention group at baseline, post treatment, one month, and six months follow-up 127

60 Multiple pairwise comparisons of mean KOOS functional disability (sport) scores for control group at baseline, post treatment, one month, and six months follow-up 127

61 One-way ANOVA on mean depression score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 128

62 Summary table of mixed repeated measure ANOVA for mean depression score (between subject effects) 129

63 Summary table of mixed repeated measure ANOVA for mean depression score (within subject effects) 129

64 Multiple pairwise comparisons of mean depression scores for intervention group at baseline, post treatment, one month, and six months follow-up 132

65 Multiple pairwise comparisons of mean depression scores for control group at baseline, post treatment, one month, and six months follow-up 132

66 One-way ANOVA on mean anxiety score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 133

67 Summary table of mixed repeated measure ANOVA for mean anxiety score (between subject effects) 134

68 Summary table of mixed repeated measure ANOVA for mean anxiety score (within subject effects) 134

69 Multiple pairwise comparisons of mean anxiety scores for intervention group at baseline, post treatment, one month, and six months follow-up 136

70 Multiple pairwise comparisons of mean anxiety scores for control group at baseline, post treatment, one month, and six months follow-up 136

71 One-way ANOVA on mean stress score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 137

72 Summary table of mixed repeated measure ANOVA for mean stress score (between subject effects) 138

73 Summary table of mixed repeated measure ANOVA for mean stress score (within subject effects) 138

74 Multiple pairwise comparisons of mean stress scores for intervention group at baseline, post treatment, one month, and six months follow-up 141

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75 Multiple pairwise comparisons of mean stress scores for control group at baseline, post treatment, one month, and six months follow-up 141

76 One-way ANOVA on mean fear-avoidance beliefs (work) score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 142

77 Summary table of mixed repeated measure ANOVA for mean fear-avoidance beliefs (work) score (between subject effects) 143

78 Summary table of mixed repeated measure ANOVA for mean fear-avoidance beliefs (work) score (within subject effects) 143

79 Multiple pairwise comparisons of mean fear-avoidance beliefs (work) scores for intervention group at baseline, post treatment, one month, and six months follow-up 145

80 Multiple pairwise comparisons of mean fear-avoidance beliefs (work) scores for control group at baseline, post treatment, one month, and six months follow-up 146

81 One-way ANOVA on mean fear-avoidance beliefs (physical activity) score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 147

82 Summary table of mixed repeated measure ANOVA for mean fear-avoidance beliefs (physical activity) score (between subject effects) 148

83 Summary table of mixed repeated measure ANOVA for mean fear-avoidance beliefs (physical activity) score (within subject effects) 148

84 Multiple pairwise comparisons of mean fear-avoidance beliefs (physical activity) scores for intervention group at baseline, post treatment, one month, and six months follow-up 150

85 Multiple pairwise comparisons of mean fear-avoidance beliefs (physical activity) scores for control group at baseline, post treatment, one month, and six months follow-up 151

86 One-way ANOVA on mean pain catastrophising score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 152

87 Summary table of mixed repeated measure ANOVA for mean pain catastrophising score (between subject effects) 153

88 Summary table of mixed repeated measure ANOVA for mean pain catastrophising score (within subject effects) 153

89 Multiple pairwise comparisons of mean pain catastrophising scores for intervention group at baseline, post treatment, one month, and six months follow-up 155

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90 Multiple pairwise comparisons of mean pain catastrophising scores for control group at baseline, post treatment, one month, and six months follow-up 156

91 One-way ANOVA on mean pain self-efficacy score by participants in intervention and control group at baseline, post treatment, one month and six months follow up 157

92 Summary table of mixed repeated measure ANOVA for mean pain self-efficacy score (between subject effects) 157

93 Summary table of mixed repeated measure ANOVA for mean pain self-efficacy score (within subject effects) 158

94 Multiple pairwise comparisons of mean pain self-efficacy scores for intervention group at baseline, post treatment, one month, and six months follow-up 160

95 Multiple pairwise comparisons of mean pain self-efficacy scores for control group at baseline, post treatment, one month, and six months follow-up 160

96 Summary of the outcome measures 161

97 Summary of findings 175

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LIST OF FIGURES Figure Page

1 Schematic drawing of an osteoarthritic joint 13

2 An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: A report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) 31

3 Simplified stepwise algorithm for the pharmacological management of knee osteoarthritis. Modified from the ESCEO algorithm for treatment of knee OA 32

4 Conceptual framework based on cognitive behavioural model 43

5 Schematic diagram for the development of the cognitive behavioural-based therapy module on knee OA 52

6 Schematic diagram of the development and validation of the instrument 59

7 Consort flow chart 81

8 Interaction plot between group and time for mean KOOS knee pain score 115

9 Interaction plot between group and time for mean KOOS functional disability (daily living) scores 120

10 Interaction plot between group and time for mean KOOS functional disability (sport) scores 125

11 Interaction plot between group and time for mean depression scores 130

12 Interaction plot between group and time for mean anxiety scores 134

13 Interaction plot between group and time for mean stress scores 139

14 Interaction plot between group and time for mean fear-avoidance beliefs (work) scores 143

15 Interaction plot between group and time for mean fear-avoidance beliefs (physical activity) scores 148

16 Interaction plot between group and time for mean pain catastrophising scores 153

17 Interaction plot between group and time for mean pain self-efficacy scores 158

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LIST OF ABBREVIATIONS

< Less than

> Greater than

≤ Less than or equals to

≥ Greater than or equals to

ACL Anterior cruciate ligament

ACR American Rheumatism Association

ANOVA Analysis of variance

AVE Average variance extracted

BMI Body mass index

CBT Cognitive behavioral therapy

CI Confidence interval

COMP Cartilage degradation oligomeric matrix protein

COPCORD Community Oriented Programme for Control of Rheumatic Diseases

CR Composite reliability

CTX-II Collagen Type II telopeptides

DMOADs Disease-modifying osteoarthritis drugs

ESCEO European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis European Union

FET Fisher’s exact test

FTO Fat-mass and obesity-associated

HA Hyaluronan

HR Hazards ratio

JSN Joint space narrowing

JSW Joint space width

K-L Kellgren-Lawrence

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M Mean

MD Mean difference

MRI Magnetic resonance imaging

NSAIDs Non-steroidal anti-inflammatory drugs

OA Osteoarthritis

OAI Osteoarthritis Initiative

OARSI Osteoarthritis Research Society International

OR Odds ratio

partial η2 Partial eta-square

PPT Pain pressure threshold

RR Risk ratio

SD Standard deviation

SNPs Single-nucleotide polymorphisms

SYSADOAs Symptomatic slow-acting drugs for osteoarthritis

TKA Total knee arthroplasty

uCTX-II Urinary C-terminal telopeptide

UK United Kingdom

US United States

WHO World Health Organization

WOMAC Western Ontario and McMaster Universities Arthritis Index

χ2 Chi square test

YLDs Years lived with disability

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CHAPTER 1

1 INTRODUCTION

1.1 Background

Osteoarthritis (OA) is recognized as a major challenge among the arthritis disease to public health. It is well known to be the most prevalent chronic joint disease globally. Nonetheless, it is not a solitary infection substance, but considered as a typical end stage phenotype of a wide range of disease processes which affects all joint tissues (Arden & Leyland, 2013). Hence, it is a joint degenerative disease where it has the characteristics of breakdown the articular cartilage, osteophyte formation, joint swelling, stiffness and pain. The disease progresses from an initial hypertrophy of the articular cartilage to degeneration of the cartilage and underlying bone. Osteophytes also grow throughout the affected joint. OA is a severe, agonizing and possibly life-changing joint disease and most likely affects hands, knees and hips. Pain and functional disability are the core clinical characteristics that need treatment, including non-pharmacological, pharmacological, and surgical methodologies (Bijlsma, Berenbaum, & Lafeber, 2011). However there is also possibility other indications of symptoms of OA, including local signs of inflammation. Moreover, it is not an immaculate degenerative tissue disorder but rather a dynamic marvel since it indicates characteristics of both devastation and repair.

In a recent Global Burden Disease survey, an estimated 251 million people are known to be living with knee OA globally. Musculoskeletal diseases which included OA is the second most prominent reason for functional disable as measured by years lived with disability (Vos et al., 2012).

The effect of obesity (Zeggini et al., 2012) and ageing population increased the incidence and prevalence of OA. In addition, knee OA usually affects persons aged 40 years and above (National Center for Chronic Disease Prevention and Health Promotion, 2011). It is supported by Guillemin and colleagues where they found that prevalence of knee OA was influenced by age and was more common among women aged 50 and above (Guillemin et al., 2011). In 2010, World Health Organization (WHO) assessed that 524 million people were 65 years old and above and this number is estimated to triple which represents 16% of the world's population by 2050 (National Institute of Health, 2011). Recently, there is a population-based survey on the prevalence of symptomatic hip and knee OA. It was performed in a multiregional population in France. Results found that 756 subjects had symptomatic knee OA, and 317 subjects had symptomatic hip OA, indicating the estimation of the prevalence of symptomatic knee and hip OA in France population. Besides, a recent prevalence study of knee OA was done among

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696 elderly Korean population aged 65 years old and above revealed that overall prevalence of knee OA was 38.1% for radiographic OA, 26.4% for severe radiographic OA, and 6.5% for advanced OA that needed surgery treatment (Cho et al., 2011). The Community Oriented Programme for Control of Rheumatic Diseases (COPCORD) study in Malaysia demonstrated that 9.3% of Adult Malaysians had knee pain problem, where their knee pain level increased to 23% in those over 55 years old, and 39% in those 65 years old (Veerapen, Wigley, & Valkenburg, 2007). In spite of the fact that cartilage substitution by bone marrow stem cells and implantation of autologous chondrocytes or bioengineered tissues are methods that may resolve all knee OA pain in the future, traditional treatment approaches still assume a noteworthy part in treating OA knee at present. The present treatment is educating the patient the way to control pain, expanding wellness and reinforcing muscles that can enhance joint versatility and reduce the functional disability (Ministry of Health Malaysia, 2002). The standard treatments for knee OA are non-pharmacological management, pharmacological management and surgery. According to the guidelines developed by American Rheumatism Association (ACR) for the patients with knee OA in the area of non-pharmacological management included average wedge insoles for valgus knee OA, subtalar strapped horizontal insoles for varus knee OA, medially coordinated patellar taping, manual treatment, walking aids, warm agents, tai chi, self-management programs, and psychosocial therapies. In addition, pharmacologic modalities restrictively prescribed for the underlying administration of patients with knee OA included acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid infusions; However, intraarticular hyaluronate infusions, duloxetine, and opioids are restrictively suggested in patients who had a low reaction to starting treatment. Opioid analgesics are unequivocally suggested in patients who are either not willing to experience or had contraindications for knee surgery if failed in medicinal treatment (Hochberg et al., 2012). The significance of cognitive behavioral therapy (CBT) has turned into a first-line psychosocial treatment for people with chronic pain, including younger age kids and elderly in the course of recent decades (Ehde, Dillworth, & Turner, 2014). Advancements in CBT conveyance formats (e.g., web-based, phone conveyed) and treatment in view of CBT rule that are conveyed by the health-alliance professionals besides psychologists indicated guarantee result for chronic pain issues (Cajanding, 2016; Ehde et al., 2014; Tyrer et al., 2014). Indeed, CBT is currently a treatment that conducted alone or in conjunction with therapeutic or interdisciplinary rehabilitation therapies. The efficacy of CBT for people with chronic pain has been assessed in numerous clinical trials for more than three decades, principally in studies of chronic back pain, cerebral pain, orofacial pain, or joint inflammation related pain (Ehde et al., 2014; Helminen, Sinikallio, Valjakka, Väisänen-Rouvali, & Arokoski, 2013; Jungquist et al., 2010; Lamb et al., 2010; Shahni, Shairi, AsghariMoghaddam, & Zarnaghash, 2013; Smith et al., 2015; Thorn et al., 2011).

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1.2 Statement of the problem

The point prevalence of knee OA in Malaysia today assessed and estimated to be 10–20% of the aggregate adult or elderly population (Ministry of Health Malaysia, 2010). This knee pain problem in Malaysia was more common in adults aged 40 years and above, and it affected Indian ethnicity the most. In year 2007, it was accounted for 64.8% of all complaints related to joints. Over half of those suffering knee pains had clinical evidence of OA. Besides, there were 23% of patients aged 55 years and above who grumbled in pain, and it expanded to 39% in those more than 65 years old (Veerapen et al., 2007).

The burden of OA was 6th in East Asia and high-income East Pacific countries, 10th in North America, 7th in Eastern Europe but 13th in Western Europe (Vos et al., 2012). From a recent population-based study in the estimation of current and future impact of OA on health care, there were no less than an extra 26,000 people for each one million population aged 45 years and above who were assessed to have seek for advice for OA in a peripheral joint, as compared to year 2012 (Turkiewicz et al., 2014).

Knee OA patients with cardiovascular disease were at greater risk of all-cause mortality, as compared to the general population (Palazzo, Nguyen, Lefevre-Colau, Rannou, & Poiraudeau, 2016). A study done on the cause and disease specific mortality among 1163 patients aged 35 years and above with symptomatic and radiologic evidence based knee or hip OA patients. Results found that patients with OA showed higher risk of death compared with healthy individuals. Furthermore, higher mortality rate also found in knee OA patients with severe disable (Nuesch et al., 2011).

Knee OA mainly affects individual’s physical functioning, especially walking and social participation. According to WHO Global Burden of Disease study, OA ranked 11th cause of disability globally (Vos et al., 2012). Symptomatic knee OA ranked 4th leading cause of disability globally, with an estimated prevalence of 70-80% in the population aged 55 years and above (Fransen et al., 2011). In a recent French ‘‘Disability-health survey’’, individuals with knee OA compared to the non-knee OA individuals had an almost doubled higher limitation in walking and carrying objects. Results also found that knee OA mainly affected walking (22%), carrying objects (18.6%), and dressing (12.8%) (Palazzo, Ravaud, Papelard, Ravaud, & Poiraudeau, 2014). Knee OA also affects individual’s independency and psychosocial functioning besides than pain and functional disability. This may prompt changes in a person's life and the result of negative consequences on individuals’ quality of life and wellbeing (Ridder, Geenen, Kuijer, & Middendorp, 2008).

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Anti-inflammatory drugs are the mainstay of treatment for the symptoms of mild to moderate OA and are associated with various side-effects. Knee replacement is also one of the most common indication for the patients whom these drugs do not lead to an adequate response, and is increasingly recommended for patients younger than 55 years (Carr et al., 2012). However, a study of patients' inclinations and treatment given to 415 severe knee pain patients observed that generally 81% would not acknowledge surgery if offered because patients perceived pain which was not sufficient serious to consider for knee surgery (Mitchell & Hurley, 2008). Besides, in a recent qualitative interview study on patients’ and practitioners’ opinions on the management of knee OA, the researchers found that pharmacological treatments are effective for immediate relief of pain symptoms but it would evoke fear and avoidance to the patients. Furthermore, patients expressed concerns about the lack of information on knee surgery and they perceived the post-surgery period was long and painful that caused them felt fear. Those who experienced knee surgery felt disappointed and the knee pain remained after the surgery (Alami et al., 2011). Evidence suggested that cognitive behavioral model, which perceives the potential inclusion of psychological elements is essential for patients' conformity in treating OA knee pain. The efficacy of CBT interventions in treating OA pain supported that clinical trial studies in giving support to the viability of psychosocial interventions. It has extended past the original focus on pain management and that valuable impacts over varies of arthritis outcomes were found, including decreased psychological distress, enhanced marital adjustments and reduced fatigue (Keefe & Somers, 2010). The efficacy of cognitive behavioral interventions for knee OA pain management has been documented. A recent randomized controlled trial study on the effectiveness of group CBT on knee OA pain for the duration of 12 months follow up has addressed the importance of CBT intervention to the current conservative treatment care for knee OA related pain (Helminen et al., 2013). In addition, Coleman and other researchers have shown evidence that self-management education program based on social cognitive theory and CBT has significant improvement in knee pain at eight weeks and six months follow up among knee OA patients (Coleman et al., 2012). In Malaysia, CBT was evaluated for its effectiveness for the treatment of type 2 diabetes (Alvani, Mohd Zaharim, & Kimura, 2015), depression (Mukhtar, Oei, Jamil, & Yaacob, 2011) and chronic pain (Cardosa et al., 2012). Despite this evidence of the importance of CBT in chronic pain, there has been very little research evaluating psychosocial interventions for knee OA patients. In fact, there are no psychosocial interventions for patients with OA of the knee with the primary focus of reducing pain and improving physical and psychological functioning which has not been previously studied in Malaysia.

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Though anti-inflammatory drugs and knee replacement are the mainstay and conventional treatments in the management of knee OA in Malaysia, individuals with knee OA suffering low quality of life is still noted (Zakaria, Bakar, Hasmoni, Rani, & Kadir, 2009). Thus, non-pharmacological interventions are still a driving force in managing knee OA pain (Ehde et al., 2014). Therefore, our aim is to develop, implement and evaluate the effectiveness of a cognitive behavioral-based therapy module among knee OA patients that would reduce knee pain intensity, functional disability (daily living and sport), psychological distress (depression, anxiety and stress), pain catastrophising, fear-avoidance believes (physical activity and work), and improve pain self-efficacy level. The key features of cognitive behavioral intervention are the purpose of increasing patients' involvement and control in their life and its impact on their lives.

1.3 Significance of the study

The study may contribute to better care for patients with recent onset chronic knee pain to improve self-management skills in managing pain. It may heightened the potential importance of cognitive behavioral intervention aiming to reduce levels of pain, functional disability, depressive and anxiety severity symptoms, pain catastrophising, fear-avoidance beliefs and increase levels of pain self-efficacy in the management of chronic knee pain patients. The study described in this study will determine comparative efficacy of these programs and the results will assist healthcare providers who are responsible to deliver non-pharmacological interventions, investigators in the field of OA, authorities in human services administration and policy makers in planning for future arthritis education and self-management strategies, in order to effectively reduce health and economic burden of knee OA.

1.4 Research questions

Research questions to be addressed in this study are described as below:

1. Is a cognitive behavioural-based therapy module based on cognitivebehavioural model effective in reducing knee pain intensity level amongknee OA patients?

2. Is a cognitive behavioural-based therapy module based on cognitivebehavioural model effective in reducing functional disability level amongknee OA patients?

3. Is a cognitive behavioural-based therapy module based on cognitivebehavioural model effective in reducing psychological distress level amongknee OA patients?

4. Is a cognitive behavioural-based therapy module based on cognitivebehavioural model effective in reducing fear-avoidance beliefs level amongknee OA patients?

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5. Is a cognitive behavioural-based therapy module based on cognitive behavioural model effective in reducing pain catastrophising level among knee OA patients?

6. Is a cognitive behavioural-based therapy module based on cognitive behavioural model effective on improving pain self-efficacy level among knee OA patients?

1.5 General objective The general objective of this study is to develop and implement a cognitive behavioural-based therapy module based on cognitive behavioural model related to knee OA, and to evaluate its effectiveness in reducing knee pain intensity, functional disability level, and psychological outcomes among knee OA patients in Hospital Putrajaya and Hospital Serdang, Malaysia. 1.6 Specific objectives The specific objectives of the study are: 1. To determine the socio-demographic (age, gender, ethnicity, education

level, marital status, type of cohabitation, occupational, and monthly income) and clinical characteristics (pre-existing comorbidities, affected knee OA, duration of knee pain symptoms, pain intensity level, body mass index (BMI), and Kellgren-Lawrence (K-L) grade of knee OA) of knee OA patients.

2. To determine the baseline level of knee pain intensity, functional disability (daily living and sport), psychological distress (depression, anxiety and stress), fear-avoidance beliefs (physical activity and work), pain catastrophising and pain self-efficacy of knee OA patients.

3. To develop and implement a cognitive behavioural-based therapy module for knee OA patients.

4. To evaluate the effectiveness of a cognitive behavioural-based therapy module in reducing knee pain intensity, functional disability (daily living and sport), psychological distress (depression, anxiety and stress), fear-avoidance beliefs (physical activity and work) and pain catastrophising level among knee OA patients at immediate, one month and six months after intervention.

5. To evaluate the effectiveness of a cognitive behavioural-based therapy module on improving pain self-efficacy level among knee OA patients at immediate, one month and six months after intervention.

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1.7 Research hypothesis

H1: The cognitive behavioural-based therapy module is effective in reducing knee pain intensity level among knee OA patients. H2: The cognitive behavioural-based therapy module is effective in reducing functional disability (daily living) level among knee OA patients. H3: The cognitive behavioural-based therapy module is effective in reducing functional disability (sport) level among knee OA patients. H4: The cognitive behavioural-based therapy module is effective in reducing depression level among knee OA patients. H5: The cognitive behavioural-based therapy module is effective in reducing anxiety level among knee OA patients. H6: The cognitive behavioural-based therapy module is effective in reducing stress level among knee OA patients. H7: The cognitive behavioural-based therapy module is effective in reducing fear-avoidance beliefs (physical activity) level among knee OA patients. H8: The cognitive behavioural-based therapy module is effective in reducing fear-avoidance beliefs (work) level among knee OA patients. H9: The cognitive behavioural-based therapy module is effective in reducing pain catastrophising level among knee OA patients. H10: The cognitive behavioural-based therapy module is effective in improving pain self-efficacy level among knee OA patients.

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